Xintec Corporation
United Statesfrom the FDA registration address FDA establishment FEI 2938889
- Devices
- 27
- Registrations
- FDA
- FDA recalls
- 2
Catalogue
Search and filter all 27 devicesCompany details
- FDA FEI number
- 2938889
- Address
- 1660 SOUTH LOOP ROAD, ALAMEDA, CA, 94502
FDA recalls
Recalls initiated per year
- 2017 2
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2017
- 29 Oct 2017 Z-0162-2020 Class III Terminated It has been determined that a lot of fiber lasers were programmed incorrectly. As a result, the fibers from this lot will produce an error and will not allow the user to use the laser when it is plugged in.
- 23 Jun 2017 Z-2866-2017 Class II Terminated It has been determined that the reprocessing instructions may not provide sufficiently detailed information for the cleaning, disinfection and sterilization of the products listed below. The preliminary investigation indicates that validation data related to the reprocessing of these devices may not meet newly enacted standards.
Frequently asked questions
How many devices does XINTEC CORPORATION have in the registry?
The registry currently lists 27 devices for XINTEC CORPORATION. Devices recorded under merged duplicate company entries are counted once.
Which registries list XINTEC CORPORATION's devices?
Among its 27 most recently registered devices, XINTEC CORPORATION has devices listed in FDA 510(k) (27 devices).
What risk classes do XINTEC CORPORATION's devices fall under?
Among its 27 most recently registered devices, the classes recorded for XINTEC CORPORATION's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for XINTEC CORPORATION?
FDA recall records list 2 recalls initiated by XINTEC CORPORATION, the most recent initiated on 2017-10-29. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from XINTEC CORPORATION in the registry?
The most recently registered devices listed for XINTEC CORPORATION include GENERA 100 SURGICAL SYSTEM, OPTICON(TM) CONNECTOR ADAPTER II, OPTICA 60 ND;YAG SURGICAL LASER SYSTEM and PROTEGE II ER: YAG LASER SYSTEM AND ACCESSOIES (UPGRADE).